Wang Zihui, Lin Junfeng, Cai Guannan, Guan Weijie, Wu Fan, Deng Zhishan, Zhou Yumin, Zhong Nanshan, Ran Pixin
National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.
Guangzhou National Laboratory, Guangzhou International BioIsland, Guangzhou, China.
J Thorac Dis. 2025 Aug 31;17(8):5480-5491. doi: 10.21037/jtd-2025-323. Epub 2025 Aug 25.
Mild-to-moderate chronic obstructive pulmonary disease (COPD) requires treatment to delay disease progression, but this need is often overlooked. We aim to identify common clinical indicators that can reflect the risk of disease progression, rapidly informing individualized and early-stage intervention strategies.
Patients in the placebo groups of two clinical trials (NCT01455129 and ChiCTR-IIR-17012604) were included as the discovery and validation cohorts. Patients with severe conditions [i.e., forced expiratory volume in one second (FEV) ≤60%, COPD assessment test (CAT) ≥10, or frequent acute exacerbations of COPD (AECOPD) history] at baseline or experienced annualized clinically important deterioration (CID, 60 mL in FEV, 2 points in CAT, or frequent AECOPD) during follow-up were considered to have treatment needs. Sankey diagrams were employed to show the relationship between treatment needs at baseline and follow-up. Logistic regression was used to examine the association between baseline indicators and the risk of annualized CID. The incident rate ratio (IRR) was used to assess the efficiency of tiotropium in controlling annualized CID risk.
In the discovery cohort, over 50% of patients without severe conditions at baseline experienced annualized CID during follow-up. Continued smoking, smoking pack-years ≥30, and positive bronchodilator response (BDR) were associated with increased risk of annualized CID in both the discovery [odds ratio (OR) =1.96, 1.76, and 2.47, respectively] and validation cohorts (OR =2.82, 3.23, and 3.49, respectively). Tiotropium could reduce the risk of annualized CID [IRR =0.61, 95% confidence interval (CI): 0.51-0.72].
In patients with mild-to-moderate COPD, half may experience disease progression and are characterized by continued smoking, a smoking history of ≥30 pack-years, and a positive BDR. These risks of disease progression could be partly decreased with tiotropium inhalation.
轻至中度慢性阻塞性肺疾病（COPD）需要治疗以延缓疾病进展，但这一需求常常被忽视。我们旨在确定能够反映疾病进展风险的常见临床指标，以便迅速为个体化早期干预策略提供依据。
两项临床试验（NCT01455129和ChiCTR-IIR-17012604）安慰剂组的患者被纳入作为发现队列和验证队列。基线时病情严重[即一秒用力呼气容积（FEV）≤60%、慢性阻塞性肺疾病评估测试（CAT）≥10或有慢性阻塞性肺疾病频繁急性加重（AECOPD）病史]或随访期间出现年化临床显著恶化（CID；FEV下降60 mL、CAT增加2分或频繁AECOPD）的患者被视为有治疗需求。采用桑基图展示基线和随访时治疗需求之间的关系。使用逻辑回归分析来检验基线指标与年化CID风险之间的关联。采用发病率比（IRR）评估噻托溴铵控制年化CID风险的效果。
在发现队列中，超过50%基线时无严重病情的患者在随访期间出现年化CID。持续吸烟、吸烟包年数≥30以及支气管扩张剂反应阳性（BDR）在发现队列[比值比（OR）分别为1.96、1.76和2.47]和验证队列（OR分别为2.82、3.23和3.49）中均与年化CID风险增加相关。噻托溴铵可降低年化CID风险[IRR = 0.61，95%置信区间（CI）：0.51 - 0.72]。
在轻至中度慢性阻塞性肺疾病患者中，半数患者可能会出现疾病进展，其特征为持续吸烟、吸烟史≥30包年以及支气管扩张剂反应阳性。吸入噻托溴铵可部分降低这些疾病进展风险。
